Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms

NCT ID: NCT04510181

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-07-31

Brief Summary

The purpose of the study is to investigate the effect of the amino acid-based blend on growth hormone levels (measured by IGF-1) and clinical symptoms in individuals with treatment-resistant FM and low-normal hGH.

Detailed Description

Low hGH levels have been observed in approximately 1/3 of individuals with FM. Low hGH levels are hypothesized to contribute to inadequate treatment outcomes in many individuals with FM and several studies have demonstrated symptom improvement in individuals with FM and low hGH who received rhGH therapy. The amino acid-based blend represents a novel mechanism for increasing endogenous hGH production. It has been shown to produce an increase in endogenous hGH levels in healthy individuals by attenuating the inhibitory effect of somatostatin on hGH release. The amino acid-based blend may be a safe and effective treatment for FM in individuals with poorly controlled FM and low-normal hGH.

This study will investigate the effect of taking the amino acid blend on IGF-1 levels (a surrogate marker of the body's growth hormone levels), fibromyalgia symptoms, stress symptoms, body weight, and other cardiometabolic biomarkers in individuals with treatment-resistant FM and low-normal hGH.

After being informed about the study and potential risks, all eligible participants giving written informed consent will administer the amino acid-based blend daily. Standard care for fibromyalgia will continue.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amino acid-based blend

The amino acid-based blend will be administered PO daily for the study duration

Group Type: EXPERIMENTAL

amino acid-based blend

Intervention Type: DIETARY_SUPPLEMENT

blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia

Interventions

amino acid-based blend

blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Have a clinical diagnosis of FM for at least 10 years, poorly controlled FM symptom, and receiving standard of care treatment at the Private Medical Practice of Susan Pekarovics, MD

2. Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)

3. Female participants of childbearing potential will agree to avoid pregnancy during the study.

4. Capable of giving signed informed consent

Exclusion Criteria

1. Human growth hormone deficiency (GHD)

2. Individuals with a total score of ≥15 (indicating the presence of moderately severe major depression) or a score of >0 on Item 9 (suicidal ideation) on the Patient Health Questionnaire-9 (PHQ-9)

3. Pregnant women or women who wish to become pregnant

4. History of substance abuse

5. Previous treatment with recombinant human growth hormone (rhGH)

6. Individuals belonging to the following vulnerable populations: people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-English speakers, economically disadvantaged individuals, employees of the study sponsor/site.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pekarovics, Susan, MD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Pekarovics, MD

Role: PRINCIPAL_INVESTIGATOR

Pekarovics, Susan, MD

Locations

Private Medical Practics of Susan Pekarovics, MD

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kati Kareki

Role: CONTACT

kati.kereki@gmail.com

323-951-4916

Facility Contacts

Kati Kareki

Role: primary

kati.kereki@gmail.com

323-951-4916

Other Identifiers

SePe-03-2020

Identifier Type: -

Identifier Source: org_study_id